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Completed

NCT Number: NCT06461039

A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant

This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females of non-childbearing potential.
  • Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

  • Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Any contraindications for the use of the oral contraception used in the study according to the Microgynon Product Information.
  • Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening.

Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.

  • History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.

Treatment and study plan

NNC0487-0111 A

Drug

NNC0487-0111 A will be administered subcutaneously.

NNC0487-0111 C

Drug

NNC0487-0111 C will be taken orally.

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)

Drug

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.

Acetaminophen - 500 mg/15 ml

Drug

Acetaminophen - 500 mg/15 ml will be taken orally.

Primary outcomes

  1. The area under the ethinylestradiol plasma concentration time curve at steady state

    Time frame: Day 8 and Day 193

    Measured as hours picograms per milliliter (h*pg/mL).

  2. The area under the levonorgestrel plasma concentration time curve at steady state

    Time frame: Day 8 and Day 193

    Measured as hours picograms per milliliter (h*pg/mL).

Secondary outcomes

  1. Maximum ethinylestradiol plasma concentration at steady state

    Time frame: Day 8 and Day 193

    Measured as picograms per milliliter (pg/mL).

  2. Maximum levonorgestrel plasma concentration at steady state

    Time frame: Day 8 and Day 193

    Measured as picograms per milliliter (pg/mL).

  3. The area under the ethinylestradiol plasma concentration time curve at steady state

    Time frame: Day 8 and Day 135

    Measured as hours picograms per milliliter (h*pg/mL).

  4. The area under the levonorgestrel plasma concentration time curve at steady state

    Time frame: Day 8 and Day 135

    Measured as hours picograms per milliliter (h*pg/mL).

  5. Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state

    Time frame: Day 8 and Day 135

    Measured as picograms per milliliter (pg/mL).

  6. Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state

    Time frame: Day 8 and Day 135

    Measured as picograms per milliliter (pg/mL).

  7. AUC1 area under the acetaminophen concentration-time curve following a standardised meal

    Time frame: Day 1 and Day 186

    Measured as hours micro grams per milliliter (h*μg/mL).

  8. AUC2 area under the acetaminophen concentration-time curve following a standardised meal

    Time frame: Day 1 and Day 186

    Measured as hours micro grams per milliliter (h*μg/mL).

  9. Cmax,para, maximum acetaminophen plasma concentration following a standardised meal

    Time frame: Day 1 and Day 186

    Measured as micrograms per milliliter (μg/mL).

  10. AUC3 area under the acetaminophen concentration-time curve following a standardised meal

    Time frame: Day 1 and Day 128

    Measured as hours micro grams per milliliter (h*μg/mL).

  11. AUC4 area under the acetaminophen concentration-time curve following a standardised meal

    Time frame: Day 1 and Day 128

    Measured as hours micro grams per milliliter (h*μg/mL).

  12. Cmax,para, maximum acetaminophen plasma concentration following a standardised meal

    Time frame: Day 1 and Day 128

    Measured as micrograms per milliliter (μg/mL).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of the Effect of NNC0487-0111 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Females of Non-childbearing Potential

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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